UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057711 |
|---|---|
| Receipt number | R000065941 |
| Scientific Title | Mental Health of Adolescents with Type 1 Diabetes : A Scoping Review |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/10/24 14:42:53 |
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Basic information
Public title
Mental Health of Adolescents with Type 1 Diabetes : A Scoping Review
Acronym
Mental Health of Adolescents with Type 1 Diabetes : A Scoping Review
Scientific Title
Mental Health of Adolescents with Type 1 Diabetes : A Scoping Review
Scientific Title:Acronym
Mental Health of Adolescents with Type 1 Diabetes : A Scoping Review
Region
| Japan |
Condition
Condition
Type 1 diabetes/ Mental Health
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to organize and analyze recent literature on the mental health challenges and support for adolescents [ages 10-19] with Type 1 Diabetes [T1D], and to clarify the trends in research and future challenges.
Basic objectives2
Others
Basic objectives -Others
1.How does the psychological well-being and glycemic control (e.g., HbA1c levels) of adolescents with T1D influence each other?
2.What mental health challenges are experienced by adolescents (aged 10-19) with T1D in developed countries?
3.What interventions or support strategies have been studied to address these mental health challenges and improve diabetes management?
4.What are the characteristics and trends of studies that include family perspectives, particularly those involving both adolescents and their parents?
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mental Health, Mental Disorders, Depression
Key secondary outcomes
Glycemic Control
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Publication year:
Due to changes in treatment methods after 1993, this review will include studies published in 1993 or later.
Language:
This review will include articles published in English and those written in languages that the authors can accurately review.
Study type:
This review will primarily focus on original quantitative studies.
Age range:
In accordance with the definition by the World Health Organization (WHO, 2014), adolescence is defined as individuals aged 10 to 19 years.
Key exclusion criteria
Language:
Studies for which only the title and abstract are available, without full-text access, will be excluded.
Study type:
Qualitative studies, mixed-methods studies, and review articles will be excluded.
Study selection:
Studies that do not include adolescents with type 1 diabetes and focus solely on parents, family members, or healthcare professionals will be excluded.
Age range:
Studies that include participants outside the age range of 10 to 19 years will be excluded.
research materials:
Non-research materials such as rapid reports, columns, and opinion pieces will not be included in this review.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Machiko |
| Middle name | |
| Last name | Seo |
Organization
Saint Lukes International University
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
17dn001@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Machiko |
| Middle name | |
| Last name | Seo |
Organization
Saint Lukes International University
Division name
Graduate School of Nursing Science
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
Homepage URL
17dn001@slcn.ac.jp
Sponsor or person
Institute
Saint Lukes International University
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saint Lukes International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
Tel
03-3543-6391
17dn001@slcn.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
English
Management information
Registered date
| 2025 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065941
